WECK IPN915198Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 24026704697896), received between Mar 29, 2022 and Mar 28, 2023 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Material Separation” (2 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 28, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  REPORTED ISSUE: DURING A ROBOTIC PROSTATECTOMY THE APPLIER HAD BEEN USED MORE THAN TEN TIMES; ON THE LAST CLIP NEEDED THE JAW OPENED WIDER THAN THE CLIP IT WOULD NOT CLOSE AROUND THE VESSEL. THE SCREW WAS MISSING, HANDLE CAME OFF, THE SCREW WAS FOUND ON THE SURGEON'S GOWN AS HE WAS SITTING DOWN AT THE TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16628718 ↗
• MalfunctionOct 17, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT THE SCREW FELL OUT OF THE HANDLE WHILE IN SURGERY.

  Patient problems: Insufficient Information

  MAUDE report 15620445 ↗
• MalfunctionJul 27, 2022Difficult to Open or Close; Difficult to Open or Close

  AFTER SMOOTH LOADING, THE USER WAS UNABLE TO LIGATE A CLIP DURING A SURGERY. THEREFORE, HE/SHE REPLACED THE APPLIER WITH A NEW ONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15112116 ↗
• MalfunctionMar 29, 2022Material Separation; Material Separation

  SET SCREW THAT RETAINS THE HANDLE CAME OUT OF INSTRUMENT DURING SURGERY. NO PATIENT INJURY OR CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13938929 ↗